Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT04527445
Status
Recruiting
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Conditions

  • Overactive Bladder
  • Radiation Exposure
  • Urge Incontinence
  • Urgency-frequency Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Reduced radiation fluoroscopy — PROCEDURE
    See previous information about each arm
  • Conventional fluoroscopy — PROCEDURE
    See previous information about each arm

Study Details

Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings. The radiation exposure will be compared between the two groups.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Reduced Radiation Fluoroscopy
    Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
  • Active Comparator: Conventional Fluoroscopy
    The standard of care is the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set as the default.

Primary Outcome Measure

Radiation Exposure [ Time Frame: At time of procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University HealthLoma LindaCalifornia92354
Forrest Jellison, MD
[email protected]
909-558-8724

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Loma Linda University Health· Loma Linda, CA

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